NCT07722104

Brief Summary

This prospective multicenter cohort study aims to compare clinical and functional outcomes between hamstring tendon and quadriceps tendon autografts in anterior cruciate ligament (ACL) reconstruction in female athletes. Participants will be followed for two years after surgery to evaluate graft failure rates, return to sport, knee stability, and patient-reported outcomes.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
28mo left

Started Aug 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

July 19, 2026

Last Update Submit

July 19, 2026

Conditions

Anterior Cruciate Ligament InjuriesKnee Injuries

Keywords

ACL reconstructionhamstring tendonquadriceps tendonfemale athletesautograft

Outcome Measures

Primary Outcomes (1)

  • Graft failure rate

    Proportion of patients requiring revision ACL reconstruction or presenting with objetive graft rupture confirmed by MRI or arthroscopy

    24 months after surgery

Secondary Outcomes (6)

  • return to sport rate

    12 and 24 months after surgery

  • IKDC Subjective knee Evaluation Form

    6, 12 and 24 months after surgery

  • KOOS (Knee Injury and Osteoarthritis outcome Score)

    6, 12 and 24 months after surgery

  • Lysholm Knee Scoring Scale

    6, 12 and 24 months after surgery

  • Limb Symetry Index (LSI)

    6, 12 and 24 months after surgery

  • +1 more secondary outcomes

Study Arms (2)

Hamstring tendon autograft

Female athletes undergoing ACL reconstruction with hamstring tendon autograft

Procedure: Hamstring tendon autograft ACL reconstruction

Quadriceps tendon autograft

Female athletes undergoing ACL reconstruction with quadriceps tendon autograft

Procedure: Quadriceps tendon autograft ACL reconstruction

Interventions

Quadriceps tendon autograft ACL reconstructionPROCEDURE

ACL reconstruction using ipsilateral quadriceps tendon autograft with arthroscopic technique

Quadriceps tendon autograft
Hamstring tendon autograft ACL reconstructionPROCEDURE

ACL reconstruction using ipsilateral hamstring tendon autograft (semitendinosus and gracilis tendons) with arthroscopic technique

Hamstring tendon autograft

Eligibility Criteria

Age16 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Female athletes aged 16 to 35 years undergoing primary ACL reconstruction with either hamstring tendon or quadriceps tendon autograft across multiple sports medicine centers in Spain.

You may qualify if:

  • Female patients aged 16 to 35 years with skeletal maturity
  • Active athlete: minimum two training sessions per week during the six months prior to injury in pivoting sports
  • Confirmed complete ACL rupture by MRI and clinical examination
  • Primary ACL reconstruction (first ligament surgery on the index knee)
  • Time from injury to surgery no longer than 6 months
  • Signed informed consent

You may not qualify if:

  • Previous ligament surgery on either knee
  • Multiligament injury: simultaneous PCL, grade III MCL or LCL injury
  • Neuromuscular, rheumatological or systemic pathology interfering with rehabilitation or functional assessments
  • Pre-existing radiological osteoarthritis grade Kellgren-Lawrence ≥2 in the index knee
  • Inability to complete 24-month follow-up protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IMED Hospitales

Alicante, Alicante, 03540, Spain

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament InjuriesKnee Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Central Study Contacts

Luis Gutiérrez Sánchez, MD

CONTACT

625733811luis_gutierrez_sanchez@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

July 19, 2026

First Posted

July 23, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

July 23, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)